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Checkpoint Inhibitor
Nivolumab +/− Ipilimumab Before Surgery for Bladder Cancer
Phase 2
Recruiting
Led By Min Yuen Teo, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT (URETER OR RENAL PELVIS) (Cohort U): Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease
Awards & highlights
Study Summary
This trial is testing if two immunotherapy drugs can help treat bladder cancer before surgery.
Who is the study for?
This trial is for adults with bladder cancer who can't have chemotherapy. They must have a certain type of bladder cancer that hasn't spread beyond the pelvis and be fit for surgery. People with prior systemic cancer treatments, active autoimmune diseases needing steroids, recent heart attacks or strokes, HIV/AIDS, or those unwilling to use contraception are excluded.Check my eligibility
What is being tested?
The study tests if immunotherapy drugs Nivolumab alone or combined with Ipilimumab are safe before surgery without delaying it. The goal is to see if these drugs shrink the tumor to aid surgical success in bladder cancer patients.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, skin rash, fatigue, digestive issues like diarrhea, liver inflammation indicated by abnormal blood tests and hormone gland problems such as thyroid dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed high-grade cancer in my upper urinary tract.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 60 days after completion of neoadjuvant nivolumab or nivolumab in combination with ipilimumab for cisplatin-ineligible mibc, without delays due to treatment-related toxicities or progressive disease
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients who proceed to radical cystectomy and pelvic lymph node dissection (RC-PLND)
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Chills
7%
Dehydration
7%
Hyperkalaemia
7%
Hypertension
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Femur fracture
1%
Hypercalcaemia
1%
Syncope
1%
Superior vena cava syndrome
1%
Bronchial obstruction
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1, of each cycle, followed by Nivolumab 3 mg/kg on day 22 and Ipilimumab 3mg/kg and Nivolumab 1mg/kg on day 45.
Group II: Cohort 3Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg on day 1 each cycle and Nivolumab 1 mg/kg on day 1 of each cycle for a total of 3 cycles. Each cycle will be three weeks long and treatment will occur during weeks 0, 3, and 6.
Group III: Cohort 2Experimental Treatment3 Interventions
Ipilimumab 3 mg/kg and Nivolumab 1 mg/kg on day 1 of each cycle, followed by Nivolumab 3 mg/kg on day 22 of each cycle for a total of 2 cycles. Each cycle will be six weeks long. Ipilimumab and Nivolumab will occur on weeks 0 and 6 while Nivolumab alone will occur on weeks 3 and 9.
Group IV: Cohort 1Experimental Treatment2 Interventions
Nivolumab 3 mg/kg on day 1 of each cycle for a total of 5 cycles. Each cycle will be two weeks long and treatment will occur during weeks 0, 2, 4, 6, and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Radical cystectomy
2002
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,275 Total Patients Enrolled
Min Yuen Teo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had chemotherapy for bladder cancer, including treatments to boost my immune system.My bladder cancer diagnosis is mainly urothelial.I am a male willing to use contraception during and for 31 weeks after treatment.You are being held against your will for treatment of a mental or physical illness.You have a positive test for hepatitis B or hepatitis C, showing that you have an ongoing infection.I have had a stroke in the last 6 months.I have an autoimmune disease but it's under control without strong medication.I have unstable chest pain.I have had a heart attack in the last 6 months.I have a bleeding or clotting disorder but am on a stable dose of blood thinners.I haven't taken specific immune therapies for cancer, but IL-2 is okay.You are not eligible if you have moderate to severe kidney function, hearing loss, peripheral neuropathy, or if there is not enough tumor tissue available for testing. You must also be fit for surgery, be at least 18 years old, and have a certain level of physical ability.Before joining the study, your blood tests need to show specific levels of white blood cells, platelets, bilirubin, and liver enzymes. If you are taking blood-thinning medication, your dose should be consistent.I have moderate to severe heart failure.I received BCG therapy for bladder cancer less than 6 weeks ago.I have tested positive for HIV/AIDS.I am not pregnant or breastfeeding.I have a confirmed high-grade cancer in my upper urinary tract.My bladder cancer is invasive but hasn't spread beyond my bladder.I haven't had any active cancer in the last 2 years, except for early stage cancer that's been cured or doesn't need treatment.I have not had major surgery in the last 28 days, except for bladder tumor removal.I have a serious wound or fracture that is not healing.I have not had bladder radiotherapy for my muscle-invasive bladder cancer.I am using birth control during and for 23 weeks after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort U (UTUC patients) is independent from Cohorts 1 - 3. ( who are cisplatin-ineligible)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an overview of the existing research involving Nivolumab?
"Nivolumab was initially trialled in 2009 at Texas Children's Hospital, and 366 trials have been completed since. At present, 765 active clinical studies are utilizing this medication; many of these experiments taking place near Commack, New jersey."
Answered by AI
Are there vacancies for participants in this medical experiment?
"Affirmative. According to clinicaltrials.gov, this scientific experiment is actively recruiting participants and was initially posted on April 25th 2018 with a recent update on February 1st 2022. 45 individuals need to be enrolled at 7 medical sites."
Answered by AI
What is the current participant count for this clinical investigation?
"Correct. Information hosted on clinicaltrials.gov confirms that this medical trial is presently enrolling participants, with the initial post date being April 25th 2018 and a recent update taking place February 1st 2022. 45 patients are required from seven different locations for the study's completion."
Answered by AI
What conditions is Nivolumab used to ameliorate?
"Nivolumab is the most common drug prescribed to patients suffering from anti-angiogenic therapy. It also has applications in treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
What adverse effects have been documented with Nivolumab treatments?
"With some clinical data confirming its safety, nivolumab received a score of 2. Notably, there is yet to be any evidence suggesting efficacy in humans."
Answered by AI
How many Canadian health care sites are hosting this research initiative?
"Seven medical facilities are enrolling patients for this clinical trial. Primary sites include Memorial Sloan Kettering Commack, Memoral Sloan Kettering Monmouth and the iconic Memorial Sloan Kettering Cancer Center in New york City. The other four locations can be found on the study's official website."
Answered by AI
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